Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
National Institutes of Health (NIH)
Department of Health and Human Services
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this stud...
Eligibility Criteria
Inclusion
- Understands the study and agrees to complete the consent process.
- Can attend all clinic visits until the end of the study.
- Agrees to follow all study procedures.
- Will not join another study with experimental treatments during this trial, unless approved by both study sponsors.
- Generally healthy according to the study doctor.
- Physical exam and lab results show no major issues that could affect safety or study results.
- Agrees to discuss HIV risk and prevention.
- Hemoglobin levels: at least 11.0 g/dL for women and 13.0 g/dL for men.
- White blood cell count between 2,500 to 12,000/mm³ (higher levels okay if health is otherwise good and approved).
- Platelet count between 125,000 to 550,000/mm³.
- ALT enzyme level less than 2.5 times the upper limit of normal.
- Serum creatinine level within 1.1 times the upper limit of normal.
- Serum calcium level at least 8.5 mg/dL.
- Blood pressure within acceptable range (systolic 90-140 mmHg, diastolic 50-90 mmHg), with average below 140/90 mmHg and no single reading over 160/100 mmHg.
- Negative HIV test.
- Negative for Hepatitis C.
- Negative for Hepatitis B.
- Women who can become pregnant must use effective contraception from 21 days before joining the study until 8 weeks after the last vaccination and must have a negative pregnancy test on enrollment day.
- Women of pregnancy potential must agree not to seek pregnancy through methods like IVF from 21 days before joining the study until 8 weeks after the last vaccination.
Exclusion
- Breastfeeding or pregnant.
- Body mass index (BMI) of 40 or higher, unless in good health and approved.
- Diabetes, unless it is well-controlled Type 2 diabetes or gestational diabetes.
- Previous or current investigational HIV vaccine recipients (placebo recipients are allowed).
- Received non-HIV investigational vaccines within the last year, unless they are now licensed or authorized.
- Immunodeficiency or medications that impair immune response, such as high-dose steroids.
- Received blood products or immunoglobulin within 16 weeks before enrollment.
- Received certain vaccines within the last 4 weeks before enrollment.
- Received other vaccines within 14 days before enrollment.
- History of myocarditis or pericarditis.
- Started allergy immunotherapy in the past year (unless stable and approved).
- Taken investigational research agents recently.
- Serious allergic reactions to any mRNA vaccine or drugs containing polyethylene glycol.
- History of hereditary or acquired angioedema.
- Any episode of hives (urticaria) within the past year.
- Chronic hives (urticaria).
- Hives previously caused by immunization.
- Bleeding disorder that would make study procedures unsafe.
- Seizures or use of seizure medications in the past 3 years.
- Absence of spleen or non-functional spleen.
- Active duty and reserve US military personnel.
- Any other significant condition that could affect safety or participation, including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential for recurrence.
- Asthma that requires frequent or high-dose medication, recent emergency care, or multiple daily medications.
- History of certain immune-mediated conditions (mild, localized conditions may be okay).
- Allergy to local anesthetics like Novocaine or Lidocaine.
- Difficulty with venous access, such as history of intravenous drug use or problems with blood draws.
Key Trial Info
Start Date :
August 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06919016
Start Date
August 6 2025
End Date
March 25 2027
Last Update
December 16 2025
Active Locations (8)
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1
University of Alabama Medical Center (Site ID: 31788)
Birmingham, Alabama, United States, 35222
2
The Hope Clinic of the Emory Vaccine Center CRS (Site ID: 31440)
Decatur, Georgia, United States, 30030
3
Brigham and Women's Hospital (Site ID: 30007)
Boston, Massachusetts, United States, 02215
4
Columbia P&S CRS (Site ID: 30329)
New York, New York, United States, 10032